ERT - United States is hiring a Product Lead, Business Intelligence. This product/technology/process expert will direct and manage all activities related to the delivering new Business Intelligence products (Note: Service is a Product) including scope, design, architectural vision, feature definition, usability, as well as product launch, and defect management during development in support of ERT business requirements and in compliance with ERT SOPs.
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly — and with confidence.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Work closely with Product Managers regarding product requirements and project details, and ensure that functionality delivered matches market requirements.
2. Maintain and monitor project timelines and ensure accuracy in monthly reporting of project status. Includes definition of project timelines, securing of internal & external resources, process tracking, risk management (prioritization, critical paths and costs) and communication of project status.
3. Manages release process for a Product. Includes coordinating with across the organization to develop and launch a Product on-time and on-budget.
4. Communicates all potential risks (regulatory or other), operational deviations including summary root cause and CAPA metrics to Product Management personnel as necessary.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
1. Bachelor’s degree (business or science-related field preferred)
2. At least three years of experience in managing technology projects or Products
3. Effective communication skills; written and oral in English and working with and leading cross functional teams
4. Design lead thinking experience is preferred
5. Demonstrated project planning skills and track record of defining, developing, and launching successful Products
6. For those positions managing (medical) devices, these additional qualifications apply:
● Experience with (medical) devices and related technologies
● Experience creating medical data management, data transfer and data storage systems including relevant standards
● Experience creating medical devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals
● Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant
For positions managing respiratory / Cardiac Safety Products additional qualifications apply:
● Strong background in the area of Spirometry and/or ECG or similar experience in signal processing/data acquisitions of vital signs (expert knowledge in the area of respiratory diagnostics and or cardiologic diagnostic equipment preferred)
● Has worked under a Quality Management System covering medical device design, development and manufacturing.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.